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Sr. Principal Engineer, Tech Transfer

Neurocrine Biosciences

US CA San DiegoPrincipalH-1B sponsor company
Sign in to applyVerified 3h ago
Location
US CA San Diego
Work model
On-Site
Level
Principal
H-1B history
1 approvals (FY2023)
Posted
Aug 30, 2026

About this role

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie ) About the Role: Leads the design and execution of formulation and process development activities across the product lifecycle, supporting programs from early development through commercialization and delivering phase-appropriate drug products aligned with target product profiles. Manages end-to-end development activities, including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while supporting external partnerships for clinical and commercial supply. Contributes technical leadership within CMC teams, collaborating cross-functionally to advance programs, support regulatory readiness, and drive continuous improvement, while mentoring junior team members and supporting robust process and product control strategies. _ Your Contributions (include, but are not limited to): Set and drive enterprise-level strategy for drug product formulation and manufacturing across the portfolio, ensuring alignment with corporate objectives, regulatory expectations, and long-term commercial success Provide authoritative technical leadership within CMC, guiding program direction from early development through commercialization and lifecycle management, and influencing key decisions at the project and portfolio level Define and govern development strategies for formulations and manufacturing processes, applying advanced scientific principles (e.g., QbD, DoE, modeling, and statistical approaches) to establish robust, scalable, and well-controlled processes Oversee and ensure successful execution of process development, scale-up, validation, and global technology transfer activities, resolving complex technical and operational challenges to enable reliable clinical and commercial supply Lead CMC subteams and influence cross-functional teams, ensuring clear communication of program strategy, risks, timelines, and resource needs to senior leadership and stakeholders Serve as a recognized subject matter expert, providing strategic oversight and direction for complex investigations, risk assessments, and issue resolution across development and manufacturing Direct external strategy and partnerships, including selection, oversight, and performance management of CDMOs and vendors, ensuring technical excellence, compliance, and alignment with program and portfolio needs Provide executive-level oversight and final accountability for CMC regulatory strategy and deliverables (e.g., IND, IMPD, NDA, MAA), ensuring high-quality submissions and successful global regulatory interactions Establish and drive lifecycle management strategies, including CPV, CPI, and proactive risk management for critical process parameters and quality attributes, ensuring sustained product performance and compliance Champion innovation by identifying, prioritizing, and implementing enabling

Listing verified 3h ago. Applications go through the company's official careers site.

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Sr. Principal Engineer, Tech Transfer at Neurocrine Biosciences, US CA San Diego | Yoinka